Clinical Research Coordinator

Kami Mallett

P.O. Box ***, Lake Charles, LA ***02 337-***-**** ********@*******.***

Professional Summary

Focused Clinical Research Coordinator well-versed in study protocols, standard operating procedures and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring 16 years of related experience to a challenging new role.

Skills/Certifications

CPR Certified

IATA Certified/Specimen collections

Knowledge of Informed consent process

Good Clinical Practices

Medication dispensing

Patient Care

Documentation Requirements

Trial Management

Knowledge of Study Protocols, and data collection

Schedule Coordination

Project organization

Process improvement

MS Office, Inform, iMedidata, Proficiency, Clinical ink, ect.

Attention to Detail

Capable of working independently

Work History

Clinical Research Coordinator, 11/2004 to 10/2020

Lake Charles Clinical Trials – Lake Charles, LA

Conducted clinical studies according to FDA/GCP and ICH regulations and guidelines.

Provided medical care to patients, always ensuring patient safety comes first.

Scheduled subject visits within protocol windows, ensuring scheduling capacity is maximized.

Performed all defined study activities (i.e., informed consent, screening, and protocol procedures which include, but not limited to vital signs, pregnancy tests, height, weight, ECG’s etc.)

Recorded all patient information and results from tests as per protocol on required forms.

Where required, complete IP accountability logs and associated information.

Reported suspected non-compliance to relevant site staff.

Ensured that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.

Promoted the company and built a positive relationship with patients to ensure retention.

Attended site initiation meetings and all other relevant meetings to receive training on protocol.

Logged and completed information on sponsor systems and ensured all information provided was accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within time frame.

Gathered and maintained source documents, updated patient files and notes, always ensuring relevant and most up to date information is recorded.

Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

Education

A Diploma in Information Processing Technician: 1995

Jefferson Davis Technical Institute - Jennings, LA

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